BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PKR INSERT X3 NO 5 RM/LL -8MM

    MDR report key: 21323336 · Received February 6, 2025

    Report

    Report Number
    0002249697-2025-00171
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 13, 2025
    Report Date
    July 3, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    NPJ
    UDI-DI
    07613327015669
    PMA / PMN Number
    K082567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: MANUFACTURING DATE. AN EVENT REGARDING WEAR INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED VIA MAR. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR). THIS INSPECTION INDICATED 'THE IMAGES SHOWS THE (A) DISTAL AND (B) PROXIMAL SIDE OF THE TRIATHLON PKR BASEPLATE, TRIATHLON X3 INSERT, AND TRIATHLON PKR FEMORAL WITH PATTERNS OF WEAR HIGHLIGHTED ON THE BASEPLATE AND INSERT AND THE FRACTURE OF THE FEMORAL COMPONENT IS ALSO HIGHLIGHTED.' DIMENSIONAL INSPECTION: NOT PERFORMED BECAUSE THE DEVICE WAS RETURNED DAMAGED. FUNCTIONAL INSPECTION: NOT PERFORMED BECAUSE THE DEVICE WAS RETURNED DAMAGED. MATERIAL ANALYSIS: A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED: 'REVIEW OF THE TRIATHLON PKR BASEPLATE, CATALOGUE # 5620-B-502, LOT CODE ASHKA, TRIATHLON PKR INSERT X3, CATALOGUE # 5630-G-528, LOT CODE MJM3TT, AND TRIATHLON PKR FEMORAL, CATALOGUE # 5610-F 502 CONFIRMED WEAR ON THE X3 INSERT AND BASEPLATE, AS WELL AS FRACTURE OF THE PKR FEMORAL. CHARACTERISATION USING VISUAL, STEREO MICROSCOPE, AND SECONDARY ELECTRON IMAGING CONFIRMED FRACTURE OF THE PKR FEMORAL IN FATIGUE WITH FINAL FRACTURE IN OVERLOAD. NO MANUFACTURING OR MATERIAL RELATED DEFECTS WERE OBSERVED ON THE EXAMINED AREAS OF THE COMPONENTS.' -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT -PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED BY THE CUSTOMER THAT "REVISION FROM A UNI KNEE TO A TOTAL KNEE DUE TO WEAR ON THE UNI POLYETHYLENE AND PROGRESSION OF DISEASE - UPON SURGICAL APPROACH NOTICED THAT THE FEMORAL COMPONENT WAS BROKEN". THE EVENT WAS CONFIRMED VIA MAR. VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR). THIS INSPECTION INDICATED 'THE IMAGES SHOWS THE (A) DISTAL AND (B) PROXIMAL SIDE OF THE TRIATHLON PKR BASEPLATE, TRIATHLON X3 INSERT, AND TRIATHLON PKR FEMORAL WITH PATTERNS OF WEAR HIGHLIGHTED ON THE BASEPLATE AND INSERT AND THE FRACTURE OF THE FEMORAL COMPONENT IS ALSO HIGHLIGHTED.' A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED: 'REVIEW OF THE TRIATHLON PKR BASEPLATE, CATALOGUE # 5620-B-502, LOT CODE ASHKA, TRIATHLON PKR INSERT X3, CATALOGUE # 5630-G-528, LOT CODE MJM3TT, AND TRIATHLON PKR FEMORAL, CATALOGUE # 5610-F 502 CONFIRMED WEAR ON THE X3 INSERT AND BASEPLATE, AS WELL AS FRACTURE OF THE PKR FEMORAL. CHARACTERISATION USING VISUAL, STEREO MICROSCOPE, AND SECONDARY ELECTRON IMAGING CONFIRMED FRACTURE OF THE PKR FEMORAL IN FATIGUE WITH FINAL FRACTURE IN OVERLOAD. NO MANUFACTURING OR MATERIAL RELATED DEFECTS WERE OBSERVED ON THE EXAMINED AREAS OF THE COMPONENTS.' NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT "REVISION FROM A UNI KNEE TO A TOTAL KNEE DUE TO WEAR ON THE UNI POLYETHYLENE AND PROGRESSION OF DISEASE, UPON SURGICAL APPROACH NOTICED THAT THE FEMORAL COMPONENT WAS BROKEN".

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631269 TRIATHLON PKR INSERT X3 NO 5 RM/LL -8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ STRYKER ORTHOPAEDICS-MAHWAH MJM3TT 07613327015669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R